This invention relates to systems and methods for hemorrhage control and/or tissue repair of the gastrointestinal tract, and more particularly, an application system and method for effectively and efficiently bandaging a treatment area of an esophagus, stomach, duodenum, small intestine and large intestine or other structures in the gastrointestinal tract requiring hemorrhage control and/or tissue repair without damaging the gastrointestinal tract.
The esophagus is the muscular, membranous tube, through which food is passed, which extends from the pharynx to the stomach. Hemorrhage control and tissue repair are difficult to affect within the esophageal tract.
The esophagus can be severely injured resulting in hemorrhage and tissue injury through penetrating trauma or from forceful emesis causing tears termed Mallory Weiss Tears. Ulceration of the esophagus and other gastrointestinal tissues can have hemorrhage and tissue injury. The esophagus is also injured and perforated by physicians using endoscopes. Surgical resections of esophageal cancers and other lesions requiring end to end and other anastomosis can hemorrhage and have tissue injury. In cases with perforations or surgical resections of the esophagus, frequently the most serious, life threatening consequences are caused by leaks of esophageal contents into the mediastinum resulting in debilitating and life threatening infection due to lack of adequate sealing of the esophageal injury.
Esophageal varices are dilated veins of the portal systemic system which pass through the distal end of the esophagus where it meets with the lesser curvature of the stomach. These veins dilate from a diameter of a few millimeters to a diameter of up to 1 cm due to an increase in blood pressure within them, which pushes against their thin, elastic walls. This portal hypertension is a consequence of the blockage in blood flow further down the path of the portal vein at the liver when fibrosis (scar tissue) is present due to cirrhosis.
When the blood through the portal vein cannot follow its usual path through the liver, it is forced back up the vein in the direction from which it came. Because the portal vein is not constructed to withstand such strong forces, it tends to balloon out at sites of vessel weakness, such as at the base of the esophagus where the vein passes very close to the surface, causing what is clinically known as varices. Esophageal varices are a subject of much concern among the medical community due to the high rate of occurrence and severe complications of the condition. Additionally, of the incidents of esophageal varices, 50% of them will be so severe that the vein will rupture into the esophagus resulting in critical bleeding situations. Patients presenting with an initial case of bleeding esophageal varices have a 40-70% fatality rate, and recurrent bleeding is typical.
Currently there are few effective acute treatment options for patients with bleeding esophageal varices. Ideally, a treatment would be as non-invasive as possible, would not cause any side-effects, would be effective for all cases presented, and would allow for the restoration of the patient's daily lifestyle soon afterward. Unfortunately none of the treatments currently available offer all of these characteristics.
Two common treatments for esophageal varices involve the use of an endoscope to deploy a device at the bleeding site to stop the bleeding. The endoscope is a tool used in most gastrointestinal procedures. It is often used for investigation and diagnosis of upper and lower GI problems. The standard endoscope is a long tubular device. It has a control held by the doctor that manipulates the tip, which is inserted down the patient's esophagus. The endoscope has its own optics system, which is transmitted to a monitor and possible video sampling or recording system. Down the center of the endoscope is a 4 mm hole. This hole is used to insert balloons, forceps or other surgical devices to perform whatever operation is necessary in the GI tract.
One of these devices places a rubber band securely around the opening of the bleeding varix, which simply closes off the injury to the harsh environment of the gastrointestinal (GI) tract with the expectation that it will eventually heal over. However, this method of treatment is only an option for bleeding varices that are relatively small, whereas most problematic varices are often very large. The other endoscopic method of treating acute bleeding in the esophagus utilizes a balloon apparatus which is extended by a wire down the esophagus, past the esophageal-stomach junction and into the upper stomach. It is then blown-up and pulled upwards toward the esophagus. This motion applies pressure to the esophagus at the esophageal-stomach junction, which acts to stop or slow down bleeding from the ruptured varices. Unfortunately, this method is not very effective, and at times physicians find it necessary to assist the process by pouring ice water down the esophagus. Ultimately, this procedure is ineffective against large bleeds, and is only a very temporary solution as it prevents the passage of food into the stomach.
The most extreme method of treating esophageal varices involves the insertion of a transjugular intrahepatic Porto systemic shunt (TIPS) into the hepatic vein in an effort to reduce portal venous pressure. Unfortunately the TIPS procedure is a highly invasive surgery. In addition, it will not cure the immediate problem of bleeding in the esophagus.
Therefore, a need exists for effectively and efficiently controlling esophageal hemorrhaging and/or repairing esophageal or other gastrointestinal tissues. Similarly, such devices could be deployed in the urologic tracts such as the urethra using endoscopic techniques or in the bronchus using bronchoscopes to treat bleeding, perforations, fistulas or other lesions. The ability to deploy a dressing that can stop hemorrhage and seal the lesion, as well as create an antimicrobial barrier, offers great promise to substantially reduce morbidity as a result of these injuries that is poorly addressed by present endoscopic and surgical technologies and techniques. The potential to deliver dressings that clot and seal these lesions rapidly and safely using conventional endoscopes would be of great benefit.